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Closed with the IRB due to slow enrollment during COVID. Will be modifying the study with a new submission.
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The purpose of this research study is to develop a method to improve thinking difficulties in individuals who have experienced a traumatic brain injury and report experiencing difficulties in attention and concentration. This study aims to understand how cognitive rehabilitation of attention difficulties affects brain activity.
This study will compare the effectiveness of two different types of cognitive rehabilitation in moderate-to-severe (m/s) traumatic brain injury (TBI) survivors. More specifically comparisons will be made between Direct Attention Training administered via BrainHQ, and Metacognitive Strategy Training in the form of the evidence-based Goal Management Training (GMT) protocol.
These interventions will be compared to the standard of care, to each other, and their combined effectiveness will be assessed. Groups will consist of randomized individuals with moderate-to-severe TBIs who experience attention deficits. Each treatment will be administered for 4 weeks and two intervention groups will be used to counterbalance treatment order. Group 1 will receive BrainHQ first followed by GMT, while Group 2 will receive GMT first followed by BrainHQ. In addition a third group will serve as a treatment-as-usual control group.
Primary outcomes include measures of self-care, ability, adjustment and participation. Secondary outcomes include measures of cognition and brain function. And lastly, tertiary outcomes include measures of emotional and psychosocial functioning. These outcomes will be measures at baseline, following completion of the first 4 week treatment in both groups (Group 1 = BrainHQ while Group 2 = GMT), and following completion of the second 4 week treatment in both groups (Group 1 = GMT while Group 2 = BrainHQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group 1 | Experimental | This arm will receive BrainHQ for the first four weeks of the study, and Goal Management Training for the second four weeks. |
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| Intervention Group 2 | Experimental | This arm will receive Goal Management Training for the first four weeks of the study, and BrainHQ for the second four weeks. |
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| Treatment-as-usual | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BrainHQ | Behavioral | BrainHQ is a web-based "brain-training" program. The investigators will assign participants to attention specific modules that they will complete at home with the goal of "restoring" attentional functions lost through injury via repetitive tasks of graded difficulty. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of change in self-care | These will be measured via the Timed Instrumental Activities of Daily Living assessment. Participants will be timed performing common functional tasks and longer completion times indicate greater impairment. | Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline) |
| Measurement of change in ability, adjustment and participation | A composite self-report questionnaire known as the Mayo-Portland Adaptability Inventory will be used to measure functioning across these domains. This measures uses a scale from 0 to 4. The higher the score the more severe the impairment. | Measured at Baseline, Post treatment 1 (4 weeks post-baseline), Post treatment 2 (8 weeks post baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| College of Public Health and Health Professions, University of Florida | Gainesville | Florida | 32611 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Described in study description
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| Goal Management Training | Behavioral | This is a manualized, interactive, metacognitive-strategy training designed to promote a mindful approach to complex real-life tasks and reduce lapses in attention via implementation of "compensatory" mechanisms for monitoring tasks. |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |